[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-large-b-cell-lymphoma-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-large-b-cell-lymphoma-refractory":261},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,69,98,132,159,188,216,235],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100629759",false,"NCT07478848","Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas","A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T\n* ECOG Performance Status ≤ 2.\n* Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T\n* Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites\n* Subjects must have at least one site of measurable disease based on CT or FDG PET\n* Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.\n\nThe following age-specific requirements apply:\n\nWomen \\\u003C 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n\nWomen ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses \\>1 year ago; or had chemotherapy-induced menopause with last menses \\>1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug\n* Known history of vancomycin resistant enterococcus (VRE)\n* Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis\n* History of radiation pneumonitis or other grade 4 radiation-related adverse event\n* Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.\n* Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.\n* Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.\n* Active infection that required the use of antibiotics within 4 weeks prior to registration\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures","ALL","18 Years",{"count":18,"type":19},14,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas",[25,26,27,28,29],"Large B Cell Lymphoma","Non Hodgkin Lymphoma (NHL)","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[31,32,33,34,35],"non-hodgkin lymphoma","NHL","large B cell lymphoma","DLBCL","diffuse large B cell lymphoma","RECRUITING","2026-06-29",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":40},"2026-05-29",{"date":44,"type":19},"2029-01-01",{"name":46,"class":47},"Abramson Cancer Center at Penn Medicine","OTHER",1,{"id":50,"slug":4,"hasResults":10,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":48},"100576735","NCT06789159","A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)","4.1 Inclusion Criteria\n\n1. Informed consent obtained prior to any protocol mandated assessment.\n2. Age ≥ 18 years.\n3. Patient must have relapsed or refractory EBV-positive DLBCL after a minimum of 2 prior regimens of systemic therapy.\n4. Patient must have exhausted all available standard of care treatment options that could potentially provide clinical benefit.\n5. Toxicities related to prior therapy must have returned to Grade 1 or less, or if chronic must be stable. Peripheral neuropathy must be Grade 2 or less\n6. Prior anti-cancer treatment must have been completed greater than 2 weeks prior to study day 1.\n7. Patients must have measurable disease, as defined by IWG 2007 criteria.\n8. ECOG performance status score of ≤2\n9. Adequate organ function as defined by the following criteria:\n\n   1. Absolute neutrophil count \\> 1,500\u002Fmicrol (stable off any growth factor within 1 week of study drug administration)\n   2. Hemoglobin \\> 9 g\u002FdL (transfusion to achieve this level is permitted)\n   3. Platelet count \\> 75,000\u002Fmicrol (transfusion to achieve this level is NOT permitted)\n   4. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN);\n   5. Total serum bilirubin ≤ 1.5 x ULN;\n   6. Creatinine clearance≥ 60 ml\u002Fmin as calculated per Cockcroft and Gault equation.\n   7. Urinary protein \\\u003C 2+ by dipstick. If dipstick ≥ 2+, then a 24-hour urine collection can be done, and the patient may enter only if urinary protein is \\\u003C 1 g\u002F24 hour;\n10. Sexually active patients will agree to utilize birth control method during the study and for 18 weeks after the study is concluded, using effective birth control methods as defined in https:\u002F\u002Fwww.cdc.gov\u002Freproductivehealth\u002Funintendedpregnancy\u002Fpdf\u002Fcontraceptive\\_methods\\_508.pdf. See Protocol Appendix C.\n11. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\n4.2 Exclusion Criteria\n\n1. Patients with severe or active symptomatic cardiopulmonary diseases (unstable angina and\u002For congestive heart failure or peripheral vascular disease within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders; patents with effectively treated conditions (e.g. stenting for CAD) are eligible.\n2. Patients with metastatic disease with active central nervous system (CNS) involvement, defined as parenchymal brain or leptomeningeal involvement.\n3. Concurrent administration of herbal preparations.\n4. A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy.\n5. Patients currently taking drugs that inhibit or induce OATP1B1 or OATP1B3 within 5 half- lives of that agent. Examples are included in Appendix B.\n6. Patients currently taking drugs that are proton pump inhibitors (PPIs) within 5 half- lives of that agent. Examples are included in Appendix B.\n7. Patients who have received a prior organ allograft or allogeneic bone marrow transplant are eligible but must have no evidence of active GVHD and be off immunosuppressive drugs.\n8. Current non-prescription drug or alcohol dependence;\n9. For all female patients, pregnancy or breastfeeding.\n10. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment.\n11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.\n12. Patients with corrected QT by Fridericia's formula (QTcF) of \\>470 ms are excluded.\n13. Patients with Post-Transplant Lymphoproliferative Disease (PTLD) are excluded.",{"count":55,"type":19},30,[22],"This is a Phase Ib in adult patients with relapsed or refractory EBV-positive DLBCL using daily oral dosing of VK-2019 in three dose escalation cohorts: 600 mg\u002Fday, 1200 mg\u002Fday, 1800 mg\u002Fday for 28 days (cycle), until progression or toxicity.",[28,29,59],"Epstein-Barr Virus (EBV) Infection","2026-06-24",{"date":62,"type":40},"2026-06-25",{"date":64,"type":19},"2026-06",{"date":66,"type":19},"2028-10-01",{"name":68,"class":47},"Pierluigi Porcu",{"id":70,"slug":4,"hasResults":10,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":79,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":48},"100570180","NCT06703892","A Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20\u002F19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies","An Open-Label, Non-Randomized, Phase I, Prospective, Dose- Finding Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20\u002F19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies","CD20\u002F19 CAR T","Inclusion Criteria:\n\n1. Subjects must be of age ≥ 18 years and ≤ 70 years\n2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent\n3. Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma - Not Otherwise Specified (DLBCL-NOS), follicular lymphoma (FL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), or High-Grade B-Cell Lymphoma (HGBCL) per the world health organization (WHO) Classification Criteria for Lymphoma (2022)\n4. Tumor cell surface expression of CD19 (+) and\u002For CD20 (+) by flow cytometry or immunohistochemistry staining\n5. Relapsed, progressive or refractory disease (defined as have not achieved a complete response) after ≥ two lines of systemic therapy, including anti-CD20 antibody and anthracycline and\u002For Relapsed, progressive or refractory disease ( defined as have not achieved a complete response) after auto-HSCT\n6. Subjects have any accessible PET-positive lesion or measurable CT-positive lesion per Lugano 2014 criteria\n7. Adequate hematologic function: absolute neutrophil count (ANC) \\> 1,000\u002FμL, absolute lymphocyte count (ALC) \\> 300\u002FμL, platelet count ≥ 75,000\u002FμL, hemoglobin ≥ 8.0 g\u002FdL\n8. Adequate hepatic function: alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN), aspartate transaminase (AST) ≤ 5 times ULN, total bilirubin ≤ 1.5 times ULN\n9. Adequate renal function: blood estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (calculated by Modification of Diet in Renal Disease (MDRD) equation)\n10. Adequate cardiac function: echocardiogram or multigated blood pool analysis (MUGA) shows left ventricular ejection fraction (LVEF) ≥ 50%; and no clinically significant electrocardiogram (ECG) findings\n11. Adequate pulmonary function: no active infection in the lungs, blood oxygen saturation in indoor air ≥ 92%\n12. No clinically significant pleural effusion determined by the investigators\n13. Estimated survival time ≥ 3 months\n14. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n15. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement\n\nExclusion Criteria:\n\n1. Previously treated with any CAR T cell product or allogenic hematopoietic stem cell transplant (HSCT)\n2. Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of the investigational product (IP)\n3. Known medical history or possible risk for taking contrast agent(s) for positron emission tomography (PET) and\u002For computed tomography (CT) scan\n4. Received any other investigational product, cell therapy, or gene therapy within 12 weeks prior to the leukapheresis\n5. Received any tyrosine kinase inhibitor within 2 weeks prior to the leukapheresis\n6. Received any systemic steroid, immunotherapy (such as immune checkpoint inhibitors, T- cell transfer therapies, monoclonal antibodies), or chemotherapy within 4 weeks prior to the leukapheresis\n7. Received any live vaccine from 2 weeks prior to the leukapheresis\n8. Subjects with human immunodeficiency virus (HIV), syphilis, Hepatitis B or C infection: HIV-1 and HIV-2 antibody positive, syphilis antibody positive, both hepatitis B virus (HBV) DNA and hepatitis B core (HBc) antibody positive, or hepatitis C virus (HCV) antibody positive\n9. Subjects with atrial or ventricular involvement by B-cell malignancies\n10. Subjects with tumor mass requiring urgent treatment within 8 weeks prior to the leukapheresis, such as ileus, tumor lysis syndrome, or vascular compression\n11. Subjects with severe disease or other uncontrolled diseases, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia (urgent intervention indicated, life- threatening consequences, or hemodynamic compromise), cardiac angioplasty or stenting, unstable angina, cerebral thrombosis, cerebral hemorrhage, hypertension (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg)\n12. Unstable pulmonary embolism, deep venous embolism, or other major arterial\u002Fvenous thromboembolism events that occurred within 6 weeks prior to the leukapheresis. If subjects receive anticoagulant therapy, the treatment dose and frequency must be stable for more than 14 weeks prior to the leukapheresis\n13. History of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic diseases, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement\n14. Female subject of childbearing potential who: a. Has positive pregnancy test result; or b. Is lactating\n15. Female subjects of childbearing potential, or male subject with female spouse\u002Fpartner of childbearing potential, who refuses to adopt at least one form of birth control from the date of signing informed consent to 12 months after GF-CART01 infusion. Acceptable forms of birth control include: a. Established use of oral, injected or implanted hormonal methods of contraception b. Placement of an intrauterine device (IUD) or intrauterine system (IUS) c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps)\n16. Any following situations that the investigators believe are not suitable for this trial and\u002For may increase the risk for subjects or interfere with the results of the study a. With severe active infections (except simple urinary tract infection and bacterial pharyngitis) b. With active central nervous system involvement by lymphoma, malignant cells in cerebrospinal fluid c. History of brain metastasis d. With uncontrolled malignancies e. Any toxicities due to prior therapy f. With any uncontrolled illness or a history of any illness","70 Years",{"count":78,"type":19},18,[22],"This is a Phase I, prospective, dose-finding study to evaluate the safety, persistence, and clinical activity of GF-CART01 in subjects aged 18-70 with relapsed or refractory (R\u002FR) B-cell hematological malignancies and failure of two-line or more standard chemotherapies or auto-hematopoietic stem cell transplantation (HSCT).This study is a traditional 3+3 dose-escalation design to observe dose-limiting toxicity (DLT), establish the maximum tolerated dose(MTD)\u002Frecommended phase 2 doses (RP2D), and preliminary efficacy of GF-CART01. RP2D may equal to or lower than MTD",[29,28,82,83,84,85],"Follicular Lymphoma ( FL)","Primary Mediastinal Large B-Cell Lymphoma-Refractory","Primary Mediastinal Large B-Cell Lymphoma-Recurrent","High-grade B-cell Lymphoma (HGBCL)",[87],"CAR T","2026-06-10",{"date":90,"type":40},"2026-06-12",{"date":92,"type":40},"2025-06-09",{"date":94,"type":19},"2027-12",{"name":96,"class":97},"GenomeFrontier Therapeutics TW Co., Ltd.","INDUSTRY",{"id":99,"slug":4,"hasResults":10,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":20,"phases":107,"briefSummary":109,"conditions":110,"keywords":117,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100607438","NCT07188558","A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19\u002FCD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","PiNACLE-H2H","Key Inclusion Criteria:\n\n1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy\n2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Transformations of indolent B-cell lymphomas (excluding Richter's transformation)\n   * DLBCL\u002FHigh-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements\n   * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Grade 3B follicular lymphoma\u002Flarge cell follicular lymphoma (FL3B)\n3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy\n4. Measurable disease by presence of \\[18F\\]-fluorodeoxyglucose PET\u002FCT positive lesion during Screening per Lugano Criteria\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria:\n\n1. Patients ineligible to receive CD19 CAR T-cell therapy\n2. Primary CNS lymphoma\n3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (Richter's transformation)\n4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years\n5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment\n6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":106,"type":19},400,[108],"PHASE3","This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19\u002FCD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.",[111,112,113,114,115,116,27,28,29],"Large B-cell Lymphoma","Lymphoma, B-Cell","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma Refractory\u002F Relapsed",[118,115,119,120,121,111],"Lymphoma","CAR T-Cell Therapy","CD19","CD19\u002FCD20","2026-06-04",{"date":124,"type":40},"2026-06-08",{"date":126,"type":40},"2026-01-12",{"date":128,"type":19},"2032-01",{"name":130,"class":97},"Lyell Immunopharma, Inc.",38,{"id":133,"slug":4,"hasResults":10,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":20,"phases":140,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100536917","NCT06271057","Golcadomide Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Golcadomide (BMS-986369) Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Inclusion Criteria:\n\n1. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures being conducted\n2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)\n3. Eligible for any commercialized market authorized anti-CD19 CAR T-cells\n4. Performance Status 0, 1, or 2\n5. With aggressive large B-cell lymphoma, including:\n\n   * diffuse large B-cell lymphoma\n   * Primary mediastinal B-cell lymphoma\n   * Any transformed follicular or marginal zone lymphoma\n   * high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma\n6. Available biopsy for centralized review\n7. With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line of treatment\n8. Total MetabolicTumor Volume (TMTV) \\> 80 ml, measured by centralized review, on standard18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +\u002F- 4 days before lymphodepletion)\n9. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if \\> 60-year-old or Cockcroft-Gault if \\\u003C60yo) \\>45 mL\u002Fmin,\n10. Adequate hepatic function:\n\n    * aspartate aminotransferase\u002Falanine aminotransferase (ALT\u002FAST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT\u002FAST must be ≤ 5.0 x ULN)\n    * Serum total bilirubin ≤ 2.0 mg\u002FdL (34 μmol\u002FL) (Note: In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ≤ 3.0 mg\u002FdL (51 μmol\u002FL))\n11. Patient covered by any social security system (France)\n12. Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators\n13. Contraception:\n\n    * For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method, as soon as consent is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, Women must refrain from donating eggs during this same period.\n\nExclusion Criteria:\n\n1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years\n2. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor\n3. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines\n4. Significant pulmonary function impairment and oxygen saturation (SaO2) \\\u003C 92% on room air\n5. Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study\n8. Current treatment with strong CYP3A4\u002F5 modulators (see appendix 13)\n9. Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential\n10. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)\n11. Person deprived of his\u002Fher liberty by a judicial or administrative decision\n12. Person hospitalized without consent\n13. Adult person under legal protection",{"count":139,"type":19},65,[141],"PHASE2","This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.\n\nApproximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.\n\nThe duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.\n\nThe primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.",[144,145,146,147],"Diffuse Large B-cell Lymphoma Refractory","Refractory Primary Mediastinal Large B-Cell Lymphoma","Refractory Transformed B-cell Non-Hodgkin Lymphoma","Refractory High Grade B-Cell Lymphoma",[149],"eligible for CAR T-cells therapy","2026-06-02",{"date":122,"type":40},{"date":153,"type":40},"2024-06-14",{"date":155,"type":19},"2028-12-31",{"name":157,"class":47},"The Lymphoma Academic Research Organisation",13,{"id":160,"slug":4,"hasResults":10,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":20,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":48},"100532193","NCT06209619","CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma","Early, Risk Adapted CC-99282 + Rituximab Post CAR T-Cell Therapy for Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n* Age ≥ 18 years at the time of consent\n* Diagnosis of B-cell Non-Hodgkin's lymphoma including either large B-cell lymphoma or follicular lymphoma. Large B-cell subtypes include but are not limited to diffuse large B-cell lymphoma, high grade B-cell lymphoma (except Burkitt's Lymphoma), primary mediastinal B-cell lymphoma, and diffuse large B cell lymphoma transformed from indolent lymphomas\n* Eastern Cooperative Oncology Group (ECOG) Score = 0-2\n* Prior receipt of standard of care CD19 directed CAR-T cell therapy including axicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel\n* Pre-CART imaging within 90 days of infusion of CD19.CAR-T for baseline disease evaluation. If patient's receive bridging therapy, imaging evaluation post bridging therapy is encouraged as part of institutional guidelines, but not mandated for inclusion\n* Evidence of objective response on PET\u002FCT at 25-100 days post CD19.CAR-T infusion compared to baseline pre-CART imaging. Objective response in this trial is defined by reduced fludeoxyglucose F-18 (FDG) uptake or reduction in mass size and includes mixed response\n* Evidence of sub-optimal response to CD19.CAR-T as defined in this trial by Deauville Score ≥ 3 on PET\u002FCT at 25-100 days post CD19.CAR-T infusion.\n* Absolute neutrophil count ≥ 7.5 x 10\\^8\u002FL (obtained within 30 days prior to initiating study treatment)\n* Evidence of partial response, though sub-optimal response as determined by persistent MRD positivity. (Example: Deauville Score 1 or 2 is eligible if MRD is positive via clonoseq).\n\n  * Hematological lab values should be without the use of growth factors or transfusion support\n  * Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy\n* Hemoglobin ≥ 8 x 10\\^9\u002FL (obtained within 30 days prior to initiating study treatment)\n\n  * Hematological lab values should be without the use of growth factors or transfusion support\n  * Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy\n* Platelets ≥ 50 x 10\\^9\u002FL (obtained within 30 days prior to initiating study treatment)\n\n  * Hematological lab values should be without the use of growth factors or transfusion support\n  * Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy\n* Estimated glomerular filtration rate (eGFR) (based on chronic kidney disease-epidemiology collaboration \\[CKD-EPI\\] \\* patient's body surface area \\[BSA\\] \\[Du Bois method\\]\u002F1.73m\\^2) ≥ 45 ml\u002Fmin (obtained within 30 days prior to initiating study treatment)\n\n  * Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy\n* Bilirubin ≤ 1.5 × upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \\> 2.0 mg\u002FdL if their conjugated bilirubin is \\\u003C 2.0 × ULN) (obtained within 30 days prior to initiating study treatment)\n\n  * Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy\n* Aspartate aminotransferase (AST) ≤ 3.0 × ULN (obtained within 30 days prior to initiating study treatment)\n\n  * Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy\n* Alanine aminotransferase (ALT) ≤ 3.0 × ULN (obtained within 30 days prior to initiating study treatment)\n\n  * Note: Changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and\u002For worsen from baseline during therapy\n* Patients must be able to provide adequate tissue samples for minimal residual disease (MRD) analysis for identification (ID) of baseline tumor deoxyribonucleic acid (DNA). 2 forms of tissue will be acceptable: optional baseline biopsy tissue post CART and prior to initiation of CC-99282, or archival tumor tissue (ex. formalin-fixed paraffin embedded \\[FFPE\\] tumor blocks) from a biopsy containing lymphoma prior to CD19.CART\n* Fridericia's formula-corrected QT interval (QTcF) \\\u003C 470 ms\n* Patients must be able to swallow\u002Fabsorb capsules\n* Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrollment. Pregnancy tests must be medically supervised with a minimum sensitivity of 25mIU\u002Fml. NOTE: a female of childbearing potential is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months, i.e. has had menses at any time in the preceding 24 consecutive months. Documentation of postmenopausal status must be provided. Further information on pregnancy testing and the definition of a female of childbearing potential located in the CC-99282 pregnancy prevention plan document\n* Females of childbearing potential are required to use 2 forms of effective methods of contraception or to agree to practice complete abstinence from the time of informed consent, without interruption, at least 28 days before starting CC-99282, throughout the entire duration of CC-99282, during dose interruptions and for at least 6 months and 2 weeks after the last dose of golcadomide (BMS-986369)\u002FCC-99282. The two contraception methods can be comprised one highly effective method and one additional effective (barrier) method. Further information on acceptable methods is located in the CC-99282 pregnancy prevention plan document\n* Male subjects with female partners must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of child bearing potential while taking CC-99282, during dose interruptions and for at least 3 months and 2 weeks following the last dose of CC-99282, even if he has undergone a successful vasectomy. Additional information regarding prevention of pregnancy as it pertains to male subjects is contained within the CC-99282 pregnancy prevention plan document\n* Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs)\n* Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non compensated hypertension (Systolic blood pressure \\>= 180mmHg or diastolic blood pressure \\>= 120mmHg)\n* Receipt of CD19.CAR-T for any indication other than that stated within the inclusions criteria\n* Concomitant use of strong CYP3A inhibitors and inducers. Examples include (but are not limited to):\n\n  * CYP3A inhibitors: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin.\n  * CYP3A inducers: carbamazepine, phenytoin, and rifampin. Patients that are able to come off moderate CYP3A inhibitors\u002Finducers will require a washout period of at least 14 days or 5 half-lives, whichever is shorter, prior to the initiation of study treatment\n* Patients who are actively receiving or have received other investigational agents, including herbal supplements, within 2 weeks or 5 half-lives of enrollment",{"count":78,"type":19},[22],"This phase I trial tests the safety, side effects and best dose of CC-99282 with rituximab for the treatment of patients who have received chimeric antigen receptor (CAR) T cell therapy for non-Hodgkins lymphoma and in whom have had a sub-optimal response early on to CAR T-cell therapy. Immunotherapy with CC-99282 may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving CC-99282 with rituximab may be a safe and effective treatment option for patients who have received CAR-T cell therapy for relapsed or refractory non-Hodgkin's lymphoma.",[169,170,171,172,84,173,174,175,176,177,83,178],"B-Cell Non-Hodgkin Lymphoma-Recurrent","Diffuse Large B-Cell Lymphoma-Recurrent","Follicular Lymphoma-Recurrent","High Grade B-Cell Lymphoma-Recurrent","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent","B-Cell Non-Hodgkin Lymphoma-Refractory","Diffuse Large B-Cell Lymphoma-Refractory","Follicular Lymphoma-Refractory","High Grade B-Cell Lymphoma-Refractory","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Refractory","2026-02-24",{"date":181,"type":40},"2026-02-27",{"date":183,"type":40},"2024-01-29",{"date":185,"type":19},"2026-12-31",{"name":187,"class":47},"Nathan Denlinger",{"id":189,"slug":4,"hasResults":10,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":20,"phases":198,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":206,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100622763","NCT07387848","Glofitamab as a Bridge to and\u002For Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lymphomas","A Phase II,Open Label, Single Arm, Multicenter Study Investigating the Efficacy and Safety of Glofitamab When Used as a Bridge to and\u002For Consolidation Post-transplant for Patients With Relapsed\u002FRefractory B-cell Lymphomas Transformed Low Grade B Cell Lymphoma) Fit and Eligible for ASCT","GLO-PACT","Inclusion Criteria:\n\n\\- To be eligible to participate in this trial, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form (ICF) ) by the patient\u002Fimpartial witness\u002Flegal representative before any trial related procedures.\n2. Male or female aged between 18 and 65 years.\n3. Ability and willingness to comply with the study protocol.\n4. Histologically confirmed diagnosis of primary refractory or relapsed DLBCL (all subtypes including primary mediastinal B cell lymphoma, high grade B cell lymphoma, large B cell lymphoma etc) or transformed low grade B cell lymphoma planned for salvage Rituximab-chemotherapy regimens followed by ASCT.\n5. Patients with a life expectancy of at least 6 months.\n6. All patients must be stable without any signs of active infection, systemic (oral or parenteral) corticosteroid or anticonvulsant therapy for at least 2 weeks prior to study treatment. Inhaled non-absorbable and topical corticosteroid use are permitted as indicated.\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks.\n8. Women of child-bearing potential and male subjects shall agree to take medically acceptable contraception measures while on study treatment and for 3 months following completion of study treatment. All women of child-bearing potential must have a negative blood pregnancy test at screening.\n\n   Women must remain abstinent or use contraceptive methods with a failure rate of ≤1% per year during the study treatment period and for 2 months after the final dose of glofitamab, 3 months after the final dose of tocilizumab (if applicable), 12 months after rituximab or chemotherapy, or 18 months after the final dose of obinutuzumab. Women must refrain from donating eggs during this same period. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (i.e., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of ≤1% per year include bilateral tubal ligation, male sterilization, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. For men who are not surgically sterile (or with azoospermia for other reasons): Investigators will discuss sperm conservation prior to initiation of study treatment for male participants. Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating sperm, as defined below: With a female partner of childbearing potential who is not pregnant, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of ≤1% per year during the study treatment period and for 2 months after the final dose of glofitamab, 3 months after the final dose of tocilizumab (if applicable), 6 months after rituximab, ICE (ifosfamide, carboplatin, and etoposide) or obinutuzumab. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n9. Patients with at least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on CT scan.\n10. Adequate hematologic function (unless attributable to the underlying disease, as established by extensive bone marrow involvement or associated with hypersplenism secondary to the involvement of the spleen by DLBCL per the investigator), defined as follows:\n\n    \\- ANC ≥1.0 x109\u002FL ( ≥1000\u002FμL) Participants with a history of benign ethnic neutropenia may be included with ANC ≥0.75x109\u002FL (≥750\u002FμL).\n\n    \\- Platelet count ≥50x109\u002FL (≥50,000\u002FμL) without a transfusion in the week prior to starting study treatment.\n11. Adequate renal function, defined as an estimated CrCl ≥ 45 mL\u002Fmin.\n12. Participants who have a negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200\u002FμL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.\n\nExclusion Criteria:\n\n* An individual, who meets ANY of the following criteria, will be excluded from participation in this trial:\n\n  1. Patients receiving any investigational drug, biological, immunological therapy within the previous 21 days before enrollment.\n  2. Presence of any severe or uncontrolled systemic disease or condition, including serious cardiac, pulmonary or renal conditions; any type of bacterial, viral, fungal or other infection that would pose a significant risk to the patient in the opinion of the investigator; or active Hepatitis B or positive HCV antibodies.\n  3. Any unresolved toxicities from prior therapy, greater than CTCAE-version 5 grade 2 at the time of starting study treatment, with exception of alopecia.\n  4. Patients with a significant cardiovascular disease or condition, including any of the following:\n\n     1. Congestive heart failure (CHF) currently requiring therapy and patients with New York Heart Association Class III\u002FIV CHF\n     2. LVEF \\\u003C 50%\n     3. Need for antiarrhythmic medical therapy for a ventricular arrhythmia or patients with uncontrolled or unstable cardiac arrhythmias\n     4. Severe conduction disturbance (e.g., second- or third-degree AV block)\n  5. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n     1. Absolute neutrophil count \\\u003C 1 x 109\u002FL (or \\\u003C 0.75 x 109\u002FL in case of ethnic neutropenia due to excess margination)\n     2. Platelet count \\\u003C 50 x 109\u002FL (Transfusion-dependent patients are excluded)\n  6. Severe hepatic and\u002For renal impairment as demonstrated by any of the following:\n\n     a. Alanine aminotransferase \\> 2.5 times the upper limit of normal (ULN) b. Aspartate aminotransferase \\> 2.5 times ULN c. Total bilirubin \\> 1.5 times ULN (Total bilirubin \\>3 times the ULN in patients with documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) d. Creatinine clearance \\\u003C 45 mL\u002Fmin (measured or calculated by Cockcroft and Gault equation). Confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN\n  7. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with all study procedures and treatment.\n  8. Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.\n  9. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products.\n  10. The presence of any contraindication to: Obinutuzumab, rituximab, or tocilizumab.\n  11. Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.\n\n  10\\. Peripheral neuropathy assessed to be Grade \\>1 according to National Cancer Institute (NCI) CTCAE) v5.0 at Enrollment.\n\n  11\\. Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, o neurodegenerative disease (note: Participants with a history of stroke who have not experienced a stroke or transient ischemic attack within the past 2 years and have no residual neurologic deficits, as judged by the investigator, are allowed).\n\n  12\\. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 2 weeks prior to the first study treatment. 13. History of other malignancy that could affect compliance with the protocol or interpretation of results, with the following exceptions:\n\nNote:\n\n* Participants with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix at any time prior to enrollment are allowed.\n* Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2 with no requirement for therapy at any time prior to enrollment are allowed.\n* Participants with any other malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible.\n* Participants receiving adjuvant endocrine therapy for non-metastatic, hormone receptor positive breast cancer for ≥2 years prior to enrollment are eligible.\n\n  14\\. Contraindications to treatment with rituximab, Obinutuzumab or tocilizumab.","65 Years",{"count":197,"type":19},40,[141],"This is an investigator-initiated, open-label, single-arm, multicenter, Phase II clinical study. The study is designed to evaluate the safety and potential effectiveness of glofitamab in adults with their disease, diffuse large B-cell lymphoma (DLBCL has either not responded to initial treatment or has returned after an initial response and who are eligible and medically fit for autologous stem cell transplantation (ASCT). Autologous stem cell transplantation is a commonly used treatment in this situation and involves high-dose chemotherapy followed by infusion of your own stem cells, which are collected from your blood several weeks before the transplant.\n\nThe purpose of this study is to assess glofitamab, which is not part of standard treatment. Glofitamab is a type of antibody designed to attach to both lymphoma cells and certain immune cells called T cells. By bringing these cells together, glofitamab may help activate the immune system so that T cells can better recognize and destroy lymphoma cells. In this study, glofitamab may be used as a \"bridge\" to transplantation and\u002For as consolidation treatment after the transplant, depending on how the disease responds to chemotherapy given before the transplant.\n\nIn recent years, newer immune-based treatments such as CAR-T cell therapy have shown benefit for patients whose lymphoma does not respond to or returns after chemotherapy. CAR-T therapy involves collecting immune cells, modifying them in a laboratory, and then reinfusing them into the patient. However, access to CAR-T therapy is limited in some regions, including Lebanon, and autologous stem cell transplantation remains an important treatment option",[28],[202,34,203,204,205],"Glofitamab","Relapse","Refractory","ASCT","NOT_YET_RECRUITING","2026-01-30",{"date":209,"type":40},"2026-02-04",{"date":211,"type":19},"2026-04-15",{"date":213,"type":19},"2031-12-15",{"name":215,"class":47},"American University of Beirut Medical Center",{"id":217,"slug":4,"hasResults":10,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":20,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":48},"100559923","NCT06570447","Glofitamab Combination With Chidamide in Patients With Recurrent\u002FRefractory DLBCL","An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n\\- To be eligible for enrollment in this study, a subject must meet all of the following criteria:\n\n1. Signed informed consent\n2. Age ≥ 18 years at the time of informed consent\n3. Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients must also be willing to comply with all study-related procedures.\n4. Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis: DLBCL-NOS, HGBCL, PMBCL and FL transformed DLBCL (trFL)\n\n   \\- A pathology report (if available) from the initial histopathological diagnosis must be provided. Patients with trFL must also provide a pathology report (if available) at the time of disease transformation. Results of all tissue tests performed at initial diagnosis should be provided, including but not limited to tests to assess cellular origin, BCL2, and MYC abnormalities (if performed).\n5. Patients must have relapsed or Cap following at least two prior lines of systemic therapy (including at least one prior regimen containing anthracene Treatment failure and at least one prior regimen containing anti-CD20 targeted therapy).\n\n   * Patients may have received Autologous haematopoietic stem cell transplant (HSCT) prior to recruitment; consolidative autologous HSCT after Chemotherapy will be counted as a line of therapy.\n   * CAR T cells plus bridging were counted as a treatment line.\n   * Local therapies (e.g., radiotherapy) will not be considered as treatment lines.\n6. Patients must have measurable disease: at least one bidimensionally measurable Lymphadenopathy, defined as \\> 1.5 cm in the longest diameter; or at least one bidimensionally measurable extranodal lesion, defined as \\> 1.0 cm in the longest diameter.\n7. Verify availability of Neoplasm tissues, unless not available per investigator assessment. Freshly collected Biopsy specimens are preferred. Representative Neoplasm tissue specimens or unstained serial sections are acceptable.\n8. Eastern Cooperative Neoplasm Group (ECOG) performance status of 0 or 1\n9. Life expectancy (as assessed by the investigator) ≥ 12 weeks\n10. Carcinoma due to prior anti Adverse event therapy must have resolved to ≤ grade 1 (except Alopecia and Hyporexia).\n11. Adequate liver function\n\n    * Bilirubin total ≤ 1.5 x upper limit of normal (ULN); patients with documented history of Gilbert's syndrome: Bilirubin total ≤ 3 x ULN with elevated indirect Bilirubin;\n    * AST\u002FALT ≤ 3 × ULN\n12. Adequate hematological function:\n\n    * Neutrophil count ≥ 1.5 x 109 cells\u002FL (1.500\u002FμL);\n    * Platelet count ≥ 75,000\u002FμL (and no Platelet transfusion within 14 days before Gpt administration on Day 1 of Cycle 1);\n    * Haemoglobin ≥ 10.0 g\u002FdL (6.2 mmol\u002FL); no Transfusion within 21 days prior to Gpt dosing on Cycle 1 Day 1\n13. Adequate renal function: Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL\u002Fmin calculated according to the C OC kroft Gault formula (see Appendix 14) (patients whose renal function is not adequately reflected by Serum creatinine levels as judged by the investigator)\n14. Negative serum Pregnancy test within 7 days prior to study treatment for women of childbearing potential. Amenorrhoea is not required for women of non-childbearing potential who are post-menopausal (≥ 12 months of non-therapeutic Surgery) or Pregnancy test sterilized (absence of ovaries and\u002For uterus). For women of childbearing potential: Agree to remain abstinent (avoid heterosexual intercourse) or to take Contraception measures.\n15. For men: Agree to remain abstinent (avoid heterosexual intercourse) or practice Contraception\n\nExclusion Criteria:\n\nAny subject who meets any of the following criteria should not be enrolled in the study:\n\n1. Inability to comply with protocol-specified hospitalization and restrictions\n2. Richter's transformation\n3. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other Infection (excluding Nail bed infection fungal) at study entry or any major Infection (as evaluated by the investigators) within 4 weeks prior to first study treatment Contacts and Locations\n4. Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)\n5. Positive test result for Chronic hepatitis B virus (HBV) Infection (defined as positive Hepatitis B surface antigen \\[HBsAg\\] serology).\n\n   \\- Patients with occult or previous HBV Infection (defined as HBsAg negative and Hepatitis B core antibody \\[HBcAb\\] positive) may be included if HBV DNA is undetectable, provided they are willing to undergo HBV DNA testing monthly during study treatment (or on Day 1 of each cycle) and monthly for at least 12 months after the last cycle, and are willing to receive appropriate antiviral therapy.\n6. Positive Hepatitis C virus (HCV) Antibody test\n\n   \\- Patients with HCV Polymerase chain reaction are eligible only if the PCR (Antibody positive) is negative for HCV RNA.\n7. Known HIV seropositive status\n\n   \\- For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations.\n8. Known or suspected chronic active Epstein-Barr Viral infection\n9. Known or suspected history of Haemophagocytic lymphohistiocytosis (H LH)\n10. Pregnancy or lactating, or planning to Pregnancy during treatment and for at least 3 months after the last dose of Gpt or within 2 months after the last dose of Glofitamab\n11. A history of treatment-emergent Immunization related Immunization associated with prior Adverse event treatment agents as follows:\n\n    * Grade 3 Adverse event, except for Grade 3 endocrinopathy managed with alternative therapy\n    * Grade 1-2 Adverse event that did not return to baseline after Therapy cessation\n12. Documented refractory to Obinutuzumab monotherapy\n13. Active autoimmune disease requiring treatment requires investigator assessment of Immunization\n14. Evidence of significant, uncontrolled concomitant disease that could affect adherence to the study protocol or interpretation of results, including Immunization, relevant Lung disorder history (Bronchospasm, Obstruction Pneumopathy), and known autoimmune Diabetes mellitus\n15. History of severe Allergy or Allergic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion Protein)\n16. History of confirmed progressive multifocal Leukoencephalopathy (PML)\n17. Current or past history of CNS Lymphoma\n18. Current or past history of CNS disease such as Stroke, Epilepsy, CNS Vasculitis, or neurodegenerative disease\n19. Another invasive Neoplasm malignant within the last 2 years (except Basal cell carcinoma and Neoplasm with a low likelihood of recurrence)\n20. Serious or extensive Angina unstable such as New York Heart disorder Association Class III or IV or objectively assessed Class C or D Cardiac disorder, Myocardial infarction within the last 6 months, unstable Arrhythmia, or Cardiovascular disorder\n21. Administration of a live attenuated vaccine within 4 weeks prior to Gpt infusion, or anticipated need for a live attenuated vaccine during the study. ( Note: Flu vaccination should only be administered during the Flu season. Patients must not receive live attenuated Flu vaccine at any time during study treatment.)\n22. Systemic Tumour necrosis agents (including but not limited to Cap Phosphorus amide, thiazolyl Purines, methotrexate, thalidomide, and anti Ammonia factor agents) within 2 weeks prior to Gpt infusions\n\n    * Corticosteroid therapy with ≤ 25 mg\u002Fday prednisone or equivalent is allowed.\n    * Inhaled and topical steroids are allowed.\n23. History of illicit drugs or Alcohol abuse within 12 months prior to screening, as judged by the investigators.\n24. Any other disease, metabolic dysfunction, Physical examination result, or clinical lab result reasonably suspecting a disease or condition that contraindicates the use of an investigational drug\n25. Investigators should review the Vaccination status of potential study patients considered for this study and follow local disease control and prevention guidelines for vaccination of any other non-live vaccinated adults aiming to prevent infectious diseases prior to the study.\n26. Any mental or Cognitive disorder that would limit the understanding, conduct, and compliance with the informed consent form;\n27. Pregnancy or lactating females, or females or male partners planning to Pregnancy during the study;\n28. Other situations that the investigators consider Discomfort to be eligible for this trial",{"count":223,"type":19},22,[141],"An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent\u002Frefractory diffuse large B-cell lymphoma.",[170,175],"2025-03-11",{"date":229,"type":40},"2025-03-13",{"date":231,"type":19},"2025-05-15",{"date":155,"type":19},{"name":234,"class":47},"Tianjin Medical University Cancer Institute and Hospital",{"id":236,"slug":4,"hasResults":10,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":20,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":48},"100522713","NCT06086197","A-RGEMOX in the Treatment of Early Relapsed\u002FRefractory DLBCL","Prospective, Single-center, Phase II Clinical Study of Anlotinib in Combination With Rituximab，Gemcitabine and Oxaliplatin (A-RGEMOX) in the Treatment of Early Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.\n* Age≥18 years old, ECOG score ≥2 points, both male and female.\n* Histopathologically confirmed as diffuse large B-cell lymphoma, not otherwise specified; high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement; high-grade B-cell lymphoma, not otherwise specified; EBV positive diffuse large B-cell lymphoma\n* Must meet one of the following conditions:\n\n  1. Early relapse: response (≥PR) to first-line systemic therapy (including rituximab and anthracyclines) and disease progression within 12 months after the end of treatment;\n  2. Refractory: first-line treatment includes rituximab and anthracyclines, and no response has been achieved with the most recent systemic treatment (≥PR).\n* At least one evaluable or measurable lesion that meets Lugano2014 criteria (evaluable lesion: PET\u002FCT examination showing increased uptake in lymph nodes or extranodal areas (higher than liver) and PET\u002FCT and\u002For CT consistent with lymphoma; Measurable lesions: nodular lesions \\>15mm in length or extragendal lesions \\>10mm in length with increased FDG uptake).\n* Adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency:\n\n  1. Neutrophil absolute count (ANC) ≥1.5×109\u002FL (1500\u002Fmm3), platelet ≥75×109\u002FL, hemoglobin ≥100g\u002FL (if bone marrow is involved, platelet ≥50×109\u002FL, ANC ≥1.0×109\u002FL, hemoglobin ≥80g\u002FL).\n  2. Liver function: serum bilirubin ≤2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (AST or ALT≤5 times the upper limit of normal value is allowed if liver is involved).\n  3. Renal function: creatinine clearance ≥60 mL\u002Fmin (estimated according to the Cockcroft-Gault formula).\n  4. Coagulation function: INR≤1.5 times the upper limit of normal value; PT and APTT≤1.5 times the upper limit of normal value.\n* Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.\n* Negative serum pregnancy test and effective contraceptive use from signing informed consent until 6 months after the last chemotherapy.\n* Life expectancy \\> 3 months.\n\nExclusion Criteria:\n\n* Pathological subtypes: primary central nervous system diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma.\n* Hemophagocytic syndrome at the time of diagnosis.\n* Central nervous system involvement secondary to lymphoma.\n* Participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study.\n* Medical history of other active malignancy within 2 years prior to enrollment, except for the following conditions:(1) adequately treated in situ of the cervix carcinoma; (2) local basal cell carcinoma or squamous cell carcinoma of skin; (3) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).\n* History of Human Immunodeficiency Virus (HIV) infection and\u002For acquired Immunodeficiency syndrome. Patients with positive hepatitis B surface antigen or hepatitis C virus antibody must be tested hepatitis B virus DNA (no more than 1000 iu\u002Fml) and HCV RNA detection (below the detection limit). Patients with hepatitis B virus carriers, or stabilized hepatitis B with anti-virus treatment and cured hepatitis C can be included.\n* Major surgery was performed within 28 days prior to study initiation.\n* Any active infection, including bacterial, fungal or viral infections, that requires systemic antiinfection therapy within 14 days prior to treatment.\n* Accompanied with severe or uncontrolled disease, including symptomatic of congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or A history of severe hemorrhagic diseases, such as hemophilia A, hemophilia B, von willebrand disease or blood transfusion or other medical intervention history of spontaneous bleeding.\n* History of stroke or intracranial hemorrhage within 6 months prior to first administration of the study drug.\n* History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.\n* Patients who must take antiplatelet drugs and anticoagulants at the same time due to underlying diseases, and there is no alternative treatment plan.\n* Continuous treatment with strong CYP1A2 and CYP3A inhibitors or inducers is required. Patients were excluded if they had taken a strong CYP1A2 and CYP3A inhibitors or inducer within 7 days prior to the first administration of the study drug (or had taken these drugs for less than 5 half-lives).\n* Hypersensitivity to the experimental drug is known.\n* Patients deemed unsuitable for the study by researchers.",{"count":242,"type":19},41,[141],"As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. However, patients with early relapse (relapse within 12 months since diagnosis or the end of first-line treatment, ER) or primary refractory had an even worse prognosis. Thus, the investigators plan to evaluate the efficacy and safety of anlotinib combined with rituximab, gemcitabine, oxaliplatin (A-RGEMOX) in the treatment of early relapsed\u002Frefractory diffuse large B-cell lymphoma.",[246,28],"Diffuse Large B-cell Lymphoma Recurrent",[248,249,250,251],"angiogenesis","anlotinib","early relapse","treatment","2024-06-23",{"date":254,"type":40},"2024-06-25",{"date":256,"type":40},"2023-10-01",{"date":258,"type":19},"2026-10",{"name":260,"class":47},"Zhejiang Cancer Hospital",""]